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NCT05081336 Clinical Trial

Low-density Lipoprotein Cholesterol Reduction With State-of-the-art Therapy in Secondary Prevention and Major Cardiovascular Adverse Events: Republic of Srpska Registry

Acute Coronary Syndrome Clinical Trial

— RS-ACS  

Official title:
Low-density Lipoprotein Cholesterol Reduction With State-of-the-art Therapy in Secondary Prevention and Major Cardiovascular Adverse Events: Republic of Srpska Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05081336
Other study ID # 022021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date March 2023

Study information
Verified date October 2021
Source University Clinical Centre of Republic of Srpska
Contact Bojan M Stanetic, MD, PhD
Phone 0038765614340
Email bojan.stanetic@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Recent trials have demonstrated that a reduction in low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular adverse events following acute coronary syndrome (ACS). However, the data coming from the real-world setting are limited. Therefore, the aim of the study is to assess the association between LDL-C changes with prognosis in patients who survive ACS. Patients with ACS will be followed for mortality and major events for at least 1 year. Changes in LDL-C between the ACS and a 6- to 10-week follow-up visit will be analysed. The associations between quartiles of LDL-C change and therapy intensity with outcomes will be investigated using adjusted Cox regression analyses.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date March 2023
Est. primary completion date January 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - acute coronary syndrome Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Statin
Statin +/- ezetimib +/- Alirocumab

Locations
Country Name City State
Bosnia and Herzegovina University Clinical Centre of the Republic of Srpska Banja Luka Republic Of Srpska

Sponsors (1)
Lead Sponsor Collaborator
University Clinical Centre of Republic of Srpska

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major Cardiovascular Adverse Events All-cause death, Acute Coronary Syndrom, Need for Myocardial Revascularization 1 year
Secondary LDL reduction 1 year
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